Comparison of Different Insoles as Conservative Treatment for Medial Knee Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

A Randomized Control Trial in Patients With Medial Knee Osteoarthritis Comparing the Clinical and Biomechanical Effect of Foot Deformity Correcting Insoles and Lateral Wedge Insoles

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04967339
• Other study ID #: 2021-InsoleStudy
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2023
• Source: University Hospital Inselspital, Berne
• Contact: Frank Klenke, Prof
• Phone: 0041 31 632 21 11
• Email: ortho[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients with early to mid-stage knee osteoarthritis (OA), a conservative treatment is indicated. In medial knee OA (when mainly the medial compartment of the knee is affected by OA), lateral wedge insoles have been promoted as cost effective and simple solution. However, clinical trials report conflicting results, with some reporting no benefit while others reported a small decrease in knee pain. Recent studies reported medial OA patients to have a tendency to a plano-valgus foot deformity, which is associated with a varus lower limb alignment and an internal rotation of the tibia. Some authors thus proposed the correction of plano-valgus deformity with foot deformity correcting insoles instead of lateral wedge insoles. Until today, only one study investigated the effect of foot deformity correcting insoles (e.g. with medial arch support) as alternative to lateral wedge insoles and reported encouraging results. However, they used lateral wedge insoles with custom arch support instead of foot deformity correcting customized insoles along (without lateral wedge). Furthermore, they did not perform any biomechanical analyses. The primary object of this study is to compare the effect of foot deformity correcting insoles for plano-valgus foot deformities and lateral wedge insoles on knee load distribution, knee pain and patient reported outcome measures in early to mid-stage medial knee OA patients after 6 and 12 months.

Description:

Osteoarthritis (OA) of the knee is defined as an inflammatory process leading to loss of protective cartilage which results in pain, disability and loss of function. Around 25% of the population between 55 and 84 years is affected by OA of the knee. It can be graded using various classification, one of the most used being the Kellgren-Lawrence-Score (KL) ranging from 1 (early) to 4 (end stage). The treatment of choice for end-stage three compartmental knee OA (KL 4) is a total knee arthroplasty (TKA), whereby the damaged/degenerated parts of the knee are removed and replaced by a prosthesis. However, in patients with early to mid-stage OA (KL 1-3), which are usually younger patients, a conservative treatment is indicated. The goal of this conservative treatment is to relieve symptoms and at best slow progression of the diseases.

In medial knee OA (when mainly the medial compartment of the knee is affected by OA), one approach is to reduce the medial compartment contact force (MCF) by shifting load from the medial (disease affected) to lateral (disease free) compartment. Thereby lateral wedge insoles have been promoted as cost effective and simple solution. The biomechanical idea of these insoles is a shift in load distribution through a change in lower limb alignment. The lateral wedge of the insoles leads to a change in foot alignment (varus hindfoot) and consequently to a change in knee alignment (valgus knee = "knock-knees") and load distribution. Biomechanical studies confirmed a reduction in external knee adduction moment (EKAM) and knee adduction angular impulse (KAAI), which are surrogate measures to estimate knee joint load distribution (e.g. MCF). However, clinical trials report conflicting results, with some reporting no benefit while others reported a small decrease in knee pain in at least some patients.

In the light of this, the connection between knee OA and foot deformities has been reassessed. One study found patients with medial knee OA to have a more pronated foot type (i.e. tendency to plano-valgus deformity) compared to an age-matched control group without OA. Other investigations found more rigid foot types in patients with medial knee OA and a more internally rotated tibia during gait as well as an inversion of the forefoot. This seems important because the hindfoot axis has a significant influence on the mechanical axis of the lower limb and thereby on the load distribution in the knee. Half a degree valgisation of the hindfoot axis leads to one-degree varisation of the mechanical axis. Furthermore, a plano-valgus foot morphology was found to lead to internal rotation of the tibia which increases shear forces in the medial knee compartment.

In summary, patients with medial knee OA tend to have a plano-valgus foot deformity which is associated with a varus lower limb alignment and an internal rotation of the tibia. Both have been associated to an increased loading of the medial compartment. Consequently, some authors proposed the correction of plano-valgus deformity with customized foot deformity correcting insoles instead of lateral wedge insoles as conservative treatment option for early to mid-stage medial knee OA. Until today, only one study investigated the effect of foot deformity correcting insoles (e.g. insoles with customized medial arch support) as alternative to lateral wedge insoles and reported encouraging results. However, they used lateral wedge insoles with and without medial arch support and did not explicitly only correct the foot deformity. Furthermore, they did not perform any biomechanical analysis, which seems important since some previous studies found significant differences in KAAI and EKAM among patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Informed Consent signed by the subject

• Aged between 40 to 80 years

• Early to mid-stage (KL 1 - 3) OA of the medial compartment of the knee based on X-ray and MRI images

• Plano-valgus foot deformity based on clinical assessment

• Availability of conventional radiographs, long-leg films, and a knee-MRI no older than 1 year at time of inclusion

• Ability to walk without walking aid for more than 15min

Exclusion Criteria:

• Contraindications and limitations of the MD as described in the instructions for use.

• Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject,

• Enrolment of the PI, his/her family members, employees and other dependent persons

• Relevant OA (Kellgren-Lawrence-Score >2) of the lateral compartment of the knee based on X-ray and MRI images

• BMI higher than 40 kg/m

• Fix varus deformities over 20 degrees

• Neurological or rheumatoid diseases of any kind

• History of high tibial osteotomy, other realignment surgery of the knee or foot

• Foot or ankle problems that contraindicated the use of footwear load-modifying interventions

• Relevant ligamentous instability

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Foot deformity correcting insoles
Foot deformity correcting insoles (e.g. insoles with medial arch support for plano-valgus deformity)
• Lateral wedge insoles
Lateral wedge insoles

Locations

Country	Name	City	State
Switzerland	Universitätsklinik für Orthopädische Chirurgie und Traumatologie Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric pain scale (NRS)		pre-treatment
Primary	Numeric pain scale (NRS)		3 months
Primary	Numeric pain scale (NRS)		6 months
Primary	Numeric pain scale (NRS)		12 months
Primary	External knee adduction moment (EKAM)		pre-treatment
Primary	External knee adduction moment (EKAM)		3 months
Primary	External knee adduction moment (EKAM)		6 months
Primary	External knee adduction moment (EKAM)		12 months
Primary	Knee adduction angular impulse (KAAI)		pre-treatment
Primary	Knee adduction angular impulse (KAAI)		3 months
Primary	Knee adduction angular impulse (KAAI)		6 months
Primary	Knee adduction angular impulse (KAAI)		12 months
Primary	Western Ontario and McMaster OA Index (WOMAC)		pre-treatment
Primary	Western Ontario and McMaster OA Index (WOMAC)		3 months
Primary	Western Ontario and McMaster OA Index (WOMAC)		6 months
Primary	Western Ontario and McMaster OA Index (WOMAC)		9 months
Primary	Western Ontario and McMaster OA Index (WOMAC)		12 months
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		pre-treatment
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		3 months
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		6 months
Primary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		12 months
Primary	Oxford-12 Knee Score (OKS)		pre-treatment
Primary	Oxford-12 Knee Score (OKS)		3 months
Primary	Oxford-12 Knee Score (OKS)		6 months
Primary	Oxford-12 Knee Score (OKS)		12 months
Primary	Knee Society Score (KSS)		pre-treatment
Primary	Knee Society Score (KSS)		3 months
Primary	Knee Society Score (KSS)		6 months
Primary	Knee Society Score (KSS)		12 months
Primary	EQ-5D		pre-treatment
Primary	EQ-5D		3 months
Primary	EQ-5D		6 months
Primary	EQ-5D		12 months